Quality Manager

The Quality Manager is responsible for the overall leadership, management, and strategic direction of the Quality Management System (QMS) for orthodontic medical device manufacturing in North Eastern America. This role ensures that all products meet the highest standards of quality, safety, and regulatory compliance for our two northeastern locations. The Quality Manager serves as the Management Representative and is accountable for maintaining compliance with FDA, ISO, and other applicable regulatory requirements while driving a culture of continuous improvement across the organization. This position reports to the Director of Quality and Regulatory Affairs. This role will be worked mainly from our Orthodent Laboratory (ODL) on Chandler Street in Buffalo, NY, and will also require occasional travel to our location in Massachusetts. Specialty Appliances is a fast-paced, high-growth, private-equity-backed company looking for strong team members to support our Quality and Regulatory Affairs team in the North East! About Us Founded in 1981, Specialty Appliances is one of the largest orthodontic labs in the country, known for our industry-leading quality, unparalleled customer service, and short lead times. In December 2019, Specialty Appliances partnered with Reynolda Equity Partners, a North Carolina-based private equity firm, to accelerate organic and inorganic growth. In this role, you will… Lead and maintain the Quality Management System (QMS) ensuring compliance with FDA, ISO 13485, and regulatory standards. Develop, update, and improve QMS policies, procedures, and controlled documents across all functions. Serve as Management Representative and primary liaison for regulatory agencies and Notified Bodies. Lead Management Review, presenting QMS performance metrics, risks, and improvement plans. Establish, track, and report quality KPIs to drive data‑based decisions. Oversee document control and change control, ensuring proper approvals, revision history, and traceability. Manage nonconformance investigations, dispositions, and trends to identify systemic issues. Oversee the CAPA program including root cause analysis, corrective actions, and effectiveness checks. Lead customer complaint handling, investigations, trending, and regulatory reporting (MDR/Vigilance). Plan, execute, and manage the internal audit program and host external audits. Manage supplier quality, including qualification, monitoring, SCARs, and supplier audits. Ensure compliance with FDA QSR/QMSR, ISO 13485, ISO 14971, and evolving regulatory requirements. Oversee product risk management activities per ISO 14971 throughout the product lifecycle. Support design controls and ensure proper DHF, DMR, and DHR documentation. Oversee incoming, in‑process, and final inspections to ensure product conformance. Manage calibration and preventive maintenance of inspection and test equipment. Support process validations (IQ/OQ/PQ) and ensure validated state is maintained. Monitor environmental controls to protect product quality and safety. Review and approve batch/lot records and release documentation for finished goods. Lead, mentor, and develop Quality department staff, including performance management. Oversee the training program ensuring compliance, competency, and documented training effectiveness. Develop and manage the Quality department budget and resource planning. Participate in new product development and transfers, ensuring regulatory and quality alignment. Ensure product identification, traceability, and labeling meet regulatory and UDI requirements. In this role, you will need to have… Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related field from an accredited institution, preferred. Minimum of 10 years of progressive experience in quality management within the medical device industry, with increasing levels of responsibility. Demonstrated experience managing a complete Quality Management System in a regulated manufacturing environment. Experience with orthodontic, dental, or Class I medical devices is highly preferred. Proven track record of successfully leading FDA inspections, Notified Body audits, and customer audits. Experience with CAPA management, complaint handling, risk management (ISO 14971), and regulatory submissions. Strong leadership and people management skills with the ability to motivate, develop, and hold teams accountable. Excellent written and verbal communication skills, with the ability to present complex quality data to all levels of the organization. Strong analytical and problem‑solving skills with a detail‑oriented approach. Ability to manage multiple priorities and projects simultaneously in a fast‑paced manufacturing environment. Demonstrated ability to work cross‑functionally and influence without direct authority. Sound judgment and decision‑making skills, particularly in situations involving product quality and patient safety. What We Offer Medical, Dental, and Vision Insurance Short-term and Long-term Disability Insurance #J-18808-Ljbffr Specialty Appliances Orthodontic Laboratory